The objective of the study is to evaluate the safety and efficacy of Abdominal EMS (Electrical Muscle Stimulation) on AWR (Abdominal Wall Restoration) in Post - Partum Women
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
EMS treatment will be performed
Southern Oklahoma Women's Health
Ardmore, Oklahoma, United States
Advanced Women's Care of the Lowcountry, PC
Bluffton, South Carolina, United States
Change in inter-recti distance (IRD), measured via Magnetic Resonance Imaging.
Up to 5 subjects will undergo MRI to evaluate effect of the treatment
Time frame: 1 month
Change in inter-recti distance (IRD), measured via UltraSound Imaging to evaluate effect of the treatment
Time frame: 1 Month, 3 Months, 6 Months
Change in Urogynecological Complaints measured using the Pelvic Floor Distress Inventory.
Pelvic Floor Distress Inventory - The PFDI-20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms.
Time frame: 1 Month, 3 Months, 6 Months
Change in Severity of Lumbopelvic and/or Abdominal Pain measured by Visual Analog Scale.
Pain will be assessed based on the Numerical Scale Response (NSR).
Time frame: 1 Month, 3 Months, 6 Months
Investigator satisfaction
Satisfaction assessment will be performed by the study investigator using using 0 - 4 -points Likert scale
Time frame: 1 Month, 3 Months, 6 Months
Subject improvement and satisfaction
Improvement and satisfaction assessment will be performed independently by the subject using 0 - 4 -points Likert scale
Time frame: 1 Month, 3 Months, 6 Months
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